The influence of gene variants on physiological responses to a Mediterranean diet - a nutritional genomics focus,

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Type 2 Diabetes; Diet and Nutrition - Other diet and nutrition disorders; Metabolic and Endocrine - Diabetes; Cardiovascular - Coronary heart disease; Cardiovascular - Hypertension

• Registration Number: ACTRN12619000178145
• Lead Sponsor: Dr. Jessica Danaher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-07
• Study Completion: 2021-12-24
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Individuals with a body mass index greater than 18.5 kg/m2, males and females aged between 18 - 55 years who are deemed eligible to participate as indicated by not meeting one or more of the exclusion criterion.

Exclusion Criteria

Participants will be excluded from participating within the project for the following reasons: Individuals with presence of psychiatric disorders, pathologic eating disorders, chronic diseases related to the metabolism of energy and nutrients (i.e. hyperthyroidism), difficulty in changing food habits, participants with special dietary needs (e.g. exclusion of whole food groups), and/or unable or unwilling to give informed consent. These exclusion criterion are set as they may influence an individual’s ability to comply with the recommendations of the nutritional intervention.
Additional exclusion criterion includes: weight instable in the previous 3 months (evident by a loss or gain of more than 10% of total body weight), pregnant or potentially pregnant, post-menopausal, taking contraindicated mediation (e.g. antibiotics, thyroid, hyperlipidemic, hypoglycemic, hypertensives, psychotropic drugs or appetite suppressants) or the use of any dietary supplement that might interfere with the results of the study. These additional exclusion criteria are set as the may exert an independent influence on microbiome and metabolic outcomes, anthropometric, biochemical, clinical, body composition (DEXA) analysis and/or dietary outcomes monitored throughout the intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood metabolites associated with glucose, fat and protein metabolism will be assessed using metabolic profiling techniques. Gas Chromatography-Mass Spectrophotometry (GC-MS). Plasma microRNA will be performed using microarray analysis and real-time-PCR. There are no specific metabolites chosen, This will be an exploratory outcome/untargeted approach. <br><br>[ A baseline measure (week 1) and week 8 of each dietary intervention (end of each diet phase). ];Gene expression analysis. Microarray kits and real-time PCR will be used for analysis of the DNA (buccal swab). There are no specific genes, rather it will be an exploratory outcome. <br><br>[ A baseline measure (week 1) and week 8 of each dietary intervention (end of each diet phase). ];Gut bacteria diversity and composition. This will be measured using faecal sample collection kits and 16S rRNA profiling.[ A baseline measure (week 1) and week 8 of each dietary intervention (end of each diet phase). ]